Stronger: Muscle Strengthening for Menopause

NCT ID: NCT06375356

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-08-31

Brief Summary

Menopause is a period of time with increased risk for muscle and bone loss. Very few people strength train regularly at least 2 times per week, and commonly reported barriers include inadequate time and resources, worries of safety, inadequate knowledge base of what moves to do and how to do them. Menopause-aged women may report unique barriers - or perceived facilitators - to strength training. This pilot study will develop and test the feasibility and acceptability of an at-home, band-based, expert-supported strength training intervention.

Detailed Description

Women are at particular risk for low muscle mass as they age, because menopause causes a dramatic reduction in circulating estrogen, which accelerates muscle decline. Preserving muscle is one of the single most important factors to maintaining lifelong independence, with bone, metabolic, cardiovascular, and cognitive health benefits. The most critical behavior for growing and preserving muscle is resistance training, and conservative estimates indicate 4 in 5 US adults do not engage in any resistance training. Commonly cited barriers for women include gender-based stigmas, discouragement, negative comments, poor knowledge of how to do resistance training, poor gym accessibility, and difficulty balancing work and family life. Finally, many menopause practitioners note that with bodyweight as a large concern, many women decrease calorie intake and increase cardiovascular (not resistance) training, further compounding muscle loss. This proposed intervention study aims to develop and pilot a muscle health building intervention with and for menopausal women.

Broadly, the investigators will identify the adherence, feasibility, acceptability, and preliminary changes of a resistance training intervention for menopausal women. The investigators will pilot the 3-month "Stronger" intervention, utilizing a protocol co-designed from focus groups. We will recruit women with menopause and randomize them into one of 2 groups: 1) single-session strength training (Stronger); or 2) "Stronger snacks," the same exercises as the single-session training but broken into single-set snack sizes that are performed throughout the week. The investigators hypothesize that the strength snacks will have the highest adherence and be the most behaviorally accessible and acceptable, but post-study interviews will also help us identify motivational differences.

Conditions

Resistance Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Shorter Resistance Training: Stronger Snacks

Home-based strength training exercises would be broken up into shorter segments throughout the day or week (e.g. a "snack" might be 3 sets of body-weight or band-based squats).

Group Type: EXPERIMENTAL

Resistance Training

Intervention Type: BEHAVIORAL

Strength exercises (3-4 sets each exercise) videos delivered electronically, participant self-tracks and self-progresses based on effort reported.

Single Session Resistance Training: Stronger Sessions

Home-based strength training exercises would be broken up into 3 weekly sessions throughout the week.

Group Type: EXPERIMENTAL

Resistance Training

Intervention Type: BEHAVIORAL

Strength exercises (3-4 sets each exercise) videos delivered electronically, participant self-tracks and self-progresses based on effort reported.

Interventions

Resistance Training

Strength exercises (3-4 sets each exercise) videos delivered electronically, participant self-tracks and self-progresses based on effort reported.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• one year of no periods or categorized as menopause
• female at birth
• English speaking

Exclusion Criteria

• unable to perform strength training movements
• currently performing regular strength training activities or exercise

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Marily Ann Oppezzo

Instructor, Med/Stanford Prevention Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Central Contacts

Instructor of Medicine

Role: CONTACT

moppezzo@stanford.edu

408-314-2629

Other Identifiers

75119

Identifier Type: -

Identifier Source: org_study_id